Device available for evaluation, returned to manufacturer on: 03/09/2018.Device evaluation: the sample was returned to the manufacturer.The pcb00 product was not returned in its original package.Visual inspection at 10x microscope magnification was performed.The plunger and pushrod were in advanced position in the preloaded insertion system.Residues of lubricant material and stuck lens were observed on the cartridge.Dent/distortions were observed, but no flashers were observed at the cartridge tip section.The condition in which the sample returned is consistent with a product that was handled and prepared for surgical process.Manufacturing record review: manufacturing record review of the production order and related document revealed that the product was manufactured and released according to specification.There was no discrepancy found during the review.A search revealed that no additional investigations requested for this production order.Labeling review: the directions for use (dfu) was reviewed.The dfu adequately provides instructions and precautions for the proper use and handling of the product.Conclusion: based on the investigation results, there is no indication of a product quality deficiency.All pertinent information available to johnson & johnson surgical vision, inc.Has been submitted.
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